| CTRI Number |
CTRI/2025/12/099218 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
observation Of Low-dose Ketamine for pain Management In Patients Undergoing Abdominal Surgery |
|
Scientific Title of Study
|
Efficacy Of Low-dose Ketamine In The Management Of Peri Operative Analgesia In Patients Undergoing Abdominal Surgery |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
chappidi reddy kishan reddy |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia 5th Floor Hi-tech building Dr. D.Y.Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9381654996 |
| Fax |
|
| Email |
crkishanreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHAHBAZ HASNAIN |
| Designation |
PROFESSOR, department of anaesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia 5th Floor Hi-tech building Dr. D.Y.Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9764621253 |
| Fax |
|
| Email |
shahbazhsnn@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHAHBAZ HASNAIN |
| Designation |
PROFESSOR, department of anaesthesiology |
| Affiliation |
DR. D.Y.PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, PIMPRI, PUNE |
| Address |
Department of Anaesthesia 5th Floor Hi-tech building Dr. D.Y.Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India
MAHARASHTRA
411018
India |
| Phone |
9764621253 |
| Fax |
|
| Email |
shahbazhsnn@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
chappidi reddy kishan reddy |
| Address |
Department of Anaesthesia 5th Floor Hi-tech building Dr. D.Y.Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| chappidi reddy kishan reddy |
Dr. D.Y.Patil Medical College Hospital and Research Centre |
Department of Anaesthesia 5th Floor Hi-tech building Dr. D.Y.Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA |
09381654996
crkishanreddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ketamine |
Inj. ketamine 0.25mg/kg will be given as bolus dose after induction followed by 0.25mg/kg/hr intravenous ketamine infusion through out the surgery till last suture as peri operative analgesia to reduce morphine usage |
| Comparator Agent |
ketamine |
Inj. ketamine 0.25mg/kg will be given as bolus dose after induction followed by normal saline infusion through out the surgery till last suture same rate and volume as ketamine group to observe the eeficacy of ketamine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Study will be conducted among the adults aged 18 and 65 years of both gender of ASA I and
II scheduled for abdominal surgery |
|
| ExclusionCriteria |
| Details |
BMI more than 35kg per sq.mt
emergency surgery
patients with uncontrolled hypertension ,aortic disection, anuerysms, myocardial ischemia
hypersensitivity to study drug |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| total morphine requirement |
wherever required |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| heart rate, mean arterial pressure , spo2 |
pre induction, post induction,every 5 minutes for next 15 minutes and every 30minutes untill the end of surgery and post operatively every 4hours for 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, randomised, controlled clinical trial designed to evaluate the effect of low-dose ketamine infusion on postoperative pain and opioid requirement in patients undergoing elective abdominal surgery under general anaesthesia. Fifty patients are randomly allocated to receive either ketamine or normal saline during surgery. Pain scores, haemodynamic parameters, total morphine consumption, recovery times, and postoperative side effects are monitored for twenty four hours. The primary aim is to determine whether ketamine reduces morphine requirement and improves postoperative analgesia compared to the control group. |